Odonate Therapeutics Announces Financial Results for the Three Months Ended March 31, 2018

May 3, 2018

SAN DIEGO--(BUSINESS WIRE)--May 3, 2018-- Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, today announced financial results for the three months ended March 31, 2018.

As of March 31, 2018, Odonate had $195.2 million in cash, compared to $198.1 million as of December 31, 2017. This decrease in cash resulted primarily from net cash used in operating activities of $12.5 million, less net proceeds of $9.8 million from the sale of common stock to the underwriters in our initial public offering in connection with the exercise of their option to purchase additional shares of common stock. Odonate’s net loss for the three months ended March 31, 2018 was $16.9 million, or $0.69 per share, compared to $2.7 million, or $0.26 per share, for the same period in 2017.

“We are excited to have recently initiated CONTESSA, our Phase 3 study investigating tesetaxel in the treatment of locally advanced or metastatic breast cancer,” said Kevin Tang, Chairman and Chief Executive Officer of Odonate. “Despite recent advances in the treatment of advanced breast cancer, there remains a significant need for new therapies that allow patients to maintain a better quality of life. We are hopeful that tesetaxel’s oral bioavailability, low pill burden, lack of history of hypersensitivity reactions and robust activity against chemotherapy-resistant tumors seen in prior studies may translate into significant benefits for patients.”

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; no history of hypersensitivity (allergic) reactions; and robust activity against chemotherapy-resistant tumors. More than 500 patients have been treated with tesetaxel across 22 clinical studies. In patients with locally advanced or metastatic breast cancer (MBC), tesetaxel was shown to have robust single-agent antitumor activity in two, multicenter, Phase 2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (MBC). CONTESSA will compare tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC, disease control rate assessed by IRC and patient-reported outcomes. To learn more, please visit www.contessastudy.com.

About Odonate Therapeutics, Inc.

Odonate Therapeutics, Inc. is a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Odonate’s initial focus is on the development of tesetaxel, an investigational, orally administered chemotherapy agent belonging to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Odonate recently initiated CONTESSA, a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer (MBC). Odonate’s goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives. To learn more, please visit www.odonate.com.

Forward-looking Statements

This press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: the outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer; our ability to obtain regulatory approval of tesetaxel; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

 
ODONATE THERAPEUTICS, INC.
Condensed Balance Sheets
(in thousands, except par value and share amounts)
   
March 31, December 31,
2018 2017
(Unaudited)
Assets
Current assets:
Cash $ 195,246 $ 198,105
Prepaid expenses   3,568   4,841
Total current assets 198,814 202,946
Property and equipment, net 202 165
Restricted cash 250 -
Other   457   383
Total assets $ 199,723 $ 203,494
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 5,166 $ 4,302
Accrued expenses   4,533   3,210
Total current liabilities 9,699 7,512
Commitments and contingencies
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized; 26,885,689 and 26,890,356 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively 244 240
Additional paid-in capital 245,953 235,034
Accumulated deficit   (56,173 )   (39,292 )
Total stockholders' equity   190,024   195,982
Total liabilities and stockholders' equity $ 199,723 $ 203,494
 
 
ODONATE THERAPEUTICS, INC.
Condensed Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
 
Three Months Ended March 31,
2018   2017
Operating expenses:
Research and development $ 14,460 $ 2,454
General and administrative   2,421   272
Total operating expenses   16,881   2,726
Net loss $ (16,881 ) $ (2,726 )
Net loss per share:
Basic and diluted $ (0.69 ) $ (0.26 )
Weighted-average shares outstanding:
Basic and diluted   24,351,019   10,464,723
 
 
ODONATE THERAPEUTICS, INC.
Condensed Statements of Cash Flows
(Unaudited)
(in thousands)
 
Three Months Ended March 31,
2018   2017
Cash flows from operating activities:
Net loss $ (16,881 ) $ (2,726 )
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation 1,011 9
Non-cash contributions for expenses 64 766
Depreciation 16 2
Changes in operating assets and liabilities:
Prepaid expenses and other assets 1,199 6
Accounts payable 815 7
Accrued expenses   1,323   166
Net cash used in operating activities (12,453 ) (1,770 )
Cash flows from investing activities:
Purchases of property and equipment   (4 )   -
Net cash used in investing activities (4 ) -
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs   9,848   10,000
Net cash provided by financing activities   9,848   10,000
Net (decrease) increase in cash and restricted cash (2,609 ) 8,230
Cash and restricted cash, beginning of period   198,105   2,599
Cash and restricted cash, end of period $ 195,496 $ 10,829
Supplemental disclosure of cash flow information:
Issuance costs included in accounts payable and accrued expenses $ - $ 14
Property and equipment purchases included in accounts payable $ 49 $ 21

Source: Odonate Therapeutics, Inc.

Odonate Therapeutics, Inc.
John G. Lemkey
Chief Financial Officer
858-731-8180
jlemkey@odonate.com

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